Kornimate/medical-research-clean huggingface dataset:
the prostate immobilization device study

Conditions: Adenocarcinoma of the Prostate

Summary: the purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.

the investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. this information was obtained using a conebeam ct scan on the treatment couch prior to a regularly scheduled radiation treatment. the conebeam ct scan is a standard tool for monitoring patient position and radiation treatment accuracy. prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. on board portal imaging was then employed using the kvkv match technique to place isocenter as simulated. for intact prostate treatment, alignment was made to implanted gold fiducial markers. for post prostatectomy patients, the alignment was to pelvic bony anatomy. after patient alignment was complete, a conebeam ct scan was obtained. the position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. for post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. these measurements were recorded weekly by the treating radiation oncologist on the physician data sheet. the difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the pids daily radiation therapist questionnaire, from 1(none) to 5(unable to insert). these results were summarized by the clinical study coordinators on the pids radiation therapist summary. patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the pids daily radiation therapist questionnaire, from 1(none) to 5(intolerable). these responses will be summarized by the clinical study coordinators on the pids radiation therapist summary.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * clinically localized t1-3 n0-1 m0 adenocarcinoma of the prostate * planned definitive radiation therapy exclusion criteria: * prior proctectomy * rectal surgery within one year * proctitis * rectal carcinoma * anal stenosis * history of inflammatory bowel disease * scleroderma * systemic sclerosis * refusal of treatment with immobilization device
physical activity in gastrointestinal cancer

Conditions: Metastatic Gastrointestinal Cancer; Physical Activity

Summary: this research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.

the physical activity program is 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training. * the goal of the aerobic training is to complete 150 minutes per week of brisk walking. * the goals of the strength, flexibility, and balance training are to engage in these activities twice per week.

Eligibility criteria:
inclusion criteria: * start of trial: * a three-month of strict inclusion criteria (phase 1). * at the end of three-months, if at least six participants have not been accrued, inclusion criteria will be expanded for a second three-month recruitment phase (phase 2). * at the end of six-months, an average of two patients per month has not been accrued, a further expand inclusion criteria (phase 3). * phase 1 (most strict) eligibility criteria include: * voluntary, signed informed consent; * diagnosis of histologically-confirmed esophageal, gastric, pancreatic, or colorectal that is metastatic or locally-advanced (unresectable); * first-line cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior adjuvant therapy if completed ≥6 months prior to start of first line chemotherapy for metastatic disease); * age greater than 65 years; * baseline weight-bearing physical activity less than 150 min∙wk-1 using the paffenbarger physical activity questionnaire; * eastern cooperative group performance status of 0, 1, or 2; * self-reported ability to walk 400-meters (approximately one city block) without sitting, leaning, or the help of another person or walker; * written physician approval; * life expectancy \>3 months; * english speaking. * phase 2 (less restrictive) eligibility criteria will loosen: -- the minimum age from greater than 65, to greater than 55; * phase 3 (least restrictive) eligibility criteria will add: -- the minimum age from greater than 55, to greater than 18. * exclusion criteria * known or suspected brain or other central nervous system metastases; * uncontrolled cardiac or pulmonary disease; * pregnant or breast feeding; * any other condition that may impede testing of the study hypothesis, make it unsafe to engage in the physical activity program, or make the participant not available for end of study assessments (determined by the investigative team).

Keywords: metastatic gastrointestinal cancer physical activity
vedic medical astrology in essential hypertension

Conditions: Essential Hypertension

Summary: previous studies have explored the correlation and impact of astrological events in relation of diseases, health concerns and relationship between birth chart and disease risk. cardiovascular conditions, sleep and fertility were found significantly associated with moon phase. however, to best of our knowledge no study has documented the impact of astrological intervention in disease management. this is a randomised, multi-center, double blind placebo controlled clinical trial with two parallel arms. this trial aims to evaluate the effectiveness of vedic medical astrological intervention for patients with mild to moderate hypertension,with respect to decreasing their blood pressure and improving their quality of life.


Eligibility criteria:
inclusion criteria: * patients age between 35 and 60 years old, male and female; * patients who meet the diagnostic criteria of essential hypertension ( * patients taking antihypertensive drugs under the supervision of physicians. * patients having understanding of our study and willing to comply with astrological protocol. * informed consent exclusion criteria: * patients who have been diagnosed as secondary hypertension or malignant hypertension * patients with comorbid conditions * patients with a chronic disease associated or psychiatric conditions which might not suitable for the study * patients who had been treated with any other alternative or complementary medicine during the previous three months
physical exercise and its impact on signs of inflammation in fibromyalgia

Conditions: Exercise Therapy; Pain

Summary: the study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Eligibility criteria:
inclusion criteria: * women with fibromyalgia, interested in exercise twice a week exclusion criteria: * other severe diseases

Keywords: fibromyalgia physical activity function pain exercise inflammation
study to evaluate the impact of obesity on airway inflammation and mechanics in asthmatics

Conditions: Asthma

Summary: in the united states there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. both are considered serious public health concerns. several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. how obesity affects asthma is not fully understood. this research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways. participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens. this research study includes optional genetic and bronchoscopy substudies.


Eligibility criteria:
inclusion criteria: * adults 18 to 70 years of age * if asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid * never smoked or limited smoking history exclusion criteria: * current upper respiratory illness (other than asthma) * illegal drug use within past month * consumption of more than 6 alcoholic drinks per week * active, pronounced rhinitis or sinusitis * pregnancy * currently taking oral steroids or steroid injection over the past month * asthma exacerbation over the past month * certain medical illnesses

Keywords: asthma, inhaled corticosteroids
infiltration analgesia after caesarean section

Conditions: Pain, Postoperative; Caesarean Section

Summary: infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. in the investigators institution, this method is used quite often. however, there is a controversy regarding the analgesic efficacy. moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods. according to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. however, the scientific evidence of the efficacy of this technique is weak. the investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic. the hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.


Eligibility criteria:
inclusion criteria: * volunteer * age over 18 years * spinal anesthesia * asa 1-2 * no allergy to used medications * no medications which have effect on pain perception exclusion criteria: * patient's refusal to participate * marked systemic disease

Keywords: postoperative pain infiltration analgesia ropivacaine caesarean section
standard of care therapy with involved field radiation therapy for selective recurrent ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: this study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. we will investigate whether the addition of involved-field rt improves 2-year pfs in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).


Eligibility criteria:
inclusion criteria: * pathologically confirmed ovarian carcinoma * patients who received "standard treatment" for each stage as a primary treatment * no. of recurrent lesions: if, all in lung, or intra-abdominal or pelvis organs - ≤ 5 if, any in liver, bone, or spinal cord - ≤ 2 * size of recurrent lesions ≤5 cm * all recurrent lesions are available for involved-field radiotherapy * within 60 days before enrollment: * absolute neutrophil count anc ≥ 500 / mm3 * platelet ≥ 50,000 / mm3 * hb ≥ 8.0 g / dl * good performance status (ecog 0-1) exclusion criteria: * brain metastasis * diffuse peritoneal carcinomatosis * malignant pleural effusion * history of previous salvage radiotherapy for recurrent lesions * history of other malignancy or severe/unstable medical condition
canakinumab map in covid-19 pneumonia with crs

Conditions: Cytokine Release Syndrome in COVID-19-induced Pneumonia

Summary: this is a global managed access program (map) to provide access to canakinumab to patients with cytokine release syndrome resulting from covid-19 pneumonia


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old; * clinical diagnosis of sars-cov-2 virus by pcr, or by other approved diagnostic methodology, or, with presumptive diagnosis of covid-19 (other respiratory causes ruled out and covid-19 test pending); * hospitalized with covid-19-induced pneumonia; * elevated crp or ferritin levels; * body weight ≥ 40kg. exclusion criteria: * eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; * on the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to tnf inhibitors and anti-il-17 agents. immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day); * use of tocilizumab within 3 weeks prior to dosing with canakinumab; * suspected or known active bacterial, fungal, or parasitic infection (besides covid-19); * patients with significant neutropenia (anc \<1000/mm3); * treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.

Keywords: canakinumab ilaris acz885 covid-19 coronavirus pneumonia crs cytokine release syndrome
adequate dairy intake on weight change in girls

Conditions: Obesity

Summary: specific aim the aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (bmi) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. . hypothesis post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.


Eligibility criteria:
inclusion criteria: * age 13-14 years old (must be this age when consent is signed) * above the 50th percentile for bmi * above the 85th percentile for bmi with approval from their primary physician * at least one and one- half years post menarche * habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. this will be inclusive of supplemental calcium and dietary intake. * willingness to increase dietary calcium (low fat \[skim, 1%, 2%\] milk or yogurt) for one year exclusion criteria: * menarche prior to age 10 * history of lactose intolerance or milk allergy * weight \>300 pounds * bmi \> 97 percentile for age and gender * pregnancy * chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been \>10 years) * use of steroids like prednisone, prednisolone, hydrocortisone, flovent, advair, or nasonex * use of weight reducing medications like meredia, alli, dexatrim or xenical * use of contraceptives like yasmin, ortho tri-cyclen, apri, aviane or depo-provera for any reason, including acne (see inclusive list) * use of acne medications like accutane or high dose vitamin a * use of adhd medications like adderall, ritalin, concerta. (per dr. ramaswamy-straterra ok) (see inclusive list) * use of seizure medications like lamictal or phenobarb (see inclusive list) * use of anti-depressants like prozac or effexor (see inclusive list) * diagnosed eating disorder * dieting behavior with weight loss \> 10 pounds in the last 3 months (if yes, consult with project manager) * metal in the skeleton (pins, rods, etc) * sibling of a child who is or has been on a dietary study in the last 5 years * total body bmc z-score below -2.0 at baseline * participating in other ongoing research protocols
the effect of attention on postural control

Conditions: ADHD - Attention Deficit Disorder with Hyperactivity; Postural Instability

Summary: objective: this study investigates the relationship between postural control and sustained attention in individuals with probable adhd. motor control issues, including balance deficits, are observed in 30-50% of children with adhd. these deficits may extend into adulthood, yet research on postural control in adults with adhd is limited. this study aims to address this gap by exploring the connection between attention and postural stability in adults with adhd. background: adhd is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, affecting both children and adults. studies have shown that postural control relies on coordinated functioning of sensory and neuromotor systems, which adhd may impact. in children, postural challenges are more pronounced in conditions requiring complex sensory integration. however, research on adults with adhd is sparse, though preliminary findings suggest postural instability and possible links to cerebellar differences. methodology: the study evaluates sustained attention and postural control in adults with adhd, using the adult adhd screening scale (asrs-5) and postural stability assessments under dual-task conditions. by examining attention-driven postural responses, the study contributes to developing therapeutic balance protocols for individuals with adhd. hypotheses: h0: no relationship exists between postural control and sustained attention in individuals with adhd. h1: a relationship exists between postural control and sustained attention in individuals with adhd. significance: this study contributes to a better understanding of the neurophysiological links


Eligibility criteria:
inclusion criteria: * volunteers between 18-30-year-olds * not having any problems with balance exclusion criteria: * having a physical injury in the last 6 months (such as ankle sprain) * having any neurological disorder * exercising regularly for the last 12 months

Keywords: adhd posture attention balance dual task
optical coherence tomography evaluation of a biodegradable polymer-based drug-eluting stent

Conditions: Coronary Artery Disease

Summary: pontina aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based biolimus a9-eluting stent (biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (gazelle stent) at 1 month after implantation.


Eligibility criteria:
inclusion criteria: * age \>50 years * de novo lesion * lesion length \<24 mm * reference vessel diameter 3 mm exclusion criteria: * low compliance to dual antiplatelet therapy * life expectancy \<1 year * allergy to any drug or substance use prior, during or after percutaneous coronary intervention * chronic renal insufficiency * low left ventricle ejection fraction (\<35%) * recent acute myocardial infarction * previous coronary intervention * off-label indication to stenting * participation in another investigation * refusal to participate to the study
prenatal test for fetal aneuploidy detection

Conditions: Aneuploidy; Trisomy 21

Summary: the purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.


Eligibility criteria:
inclusion criteria: * subject is 18yrs or older * subject has a singleton pregnancy * subject is planning to undergo chorionic villus sampling (cvs) and/or amniocentesis with current pregnancy * subject is able to provide consent exclusion criteria: * subject is pregnant with more than one fetus * subject (mother) has known aneuploidy * subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer. * subject has already undergone cvs or amniocentesis during current pregnancy prior to study enrollment.
a study of the pharmacokinetics/pharmacodynamics of gk activator (2) in type 2 diabetes patients with hepatic impairment.

Conditions: Diabetes Mellitus, Type 2

Summary: this study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of gk activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of gk activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes; * normal hepatic function, or mild or moderate hepatic impairment. exclusion criteria: * type 1 diabetes, or latent autoimmune diabetes in adults; * diabetic neuropathy, retinopathy or nephropathy; * treatment with insulin or ppar gamma agonist within 6 weeks of screening; * clinically significant cardiovascular disease.
effect of brazilian fruits peel on metabolic regulation and appetite in healthy subjects

Conditions: Healthy

Summary: the purpose of the study was to investigate how brazilian fruits peel affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (vas-visual analogue scales) in healthy volunteers. we hypothesize that certain brazilian fruits peel added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.


Eligibility criteria:
inclusion criteria: * healthy males and females * signed informed consent * bmi 20 - 28 kg/m2 with weight change \<3 kg latest 2 months * must be able to accept plant-based foods/drinks exclusion criteria: * below 18 years * uncomfortable speaking english and/or difficulties in understanding spoken english * smoking or using snuff * vegetarian or vegan * stressed by venous blood sampling or previous experience of being difficult to cannulate * receiving any drug treatment that may influence the study outcomes * pregnancy or breastfeeding

Keywords: brazilian fruit peel functional food cardiometabolic risk metabolic syndrome inflammation appetite gut hormone